The Comeback Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring fecal transplantation, bacterio therapy, fatigue, fecal microbiota transplantation
Eligibility Criteria
FMT PARTICIPANTS
Inclusion Criteria:
- Canada Criteria (2011)
- 18-65 years
- Mild-severe CFS/ME
- Fatigue Severity Scale score of 5,0-7,0
- Symptom duration for 2-15 years
Exclusion Criteria:
- Kidney failure
- Congestive heart failure
- Immuno-deficiency or use of immune-suppresive drugs
- Other disease that may explain ME/CFS symptoms discovered during diagnostic work up
- Use of antibiotics the last three months,
- Use of low dose naltrexone or Isoprinosin
- Pregnancy or breastfeeding
- Serious endogenous depression
- Chronic infectious disease (HIV, hepatitis B or C etc.)
- Introduction of new food supplements, change in diet or introduction of new medications the last three months
- Assessed not be able to follow the instructions for data and sample collection
- Very severe ME/CFS (WHO class IV)
- Symptom duration of less than 24 months or more than 15 years
- History of abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy
FMT DONORS
Inclusion criteria:
- Healthy
- Age 16-30 years
- Type 3 or 4 stool by the Bristol Stool Scale
Exclusion criteria:
- Use of peroral antibiotics past 3 months
- Use of topical antibiotics past 2 months
- Tattoo or piercing past 6 months
- Former imprisonment
- History of: -chronic diarrhea
- constipation
- inflammatory bowel disease
- colorectal polyps
- colorectal cancer
- immuno-suppression
- Obesity
- Metabolic syndrome
- Atopic skin disease
- CFS/ME
- Psychiatric disorders
- Other serious autoimmune disease
- Close relatives with serious autoimmune disease
- High risk sexual behavior
- Bowel movements that does not correspond to a Bristol Stool Scale type 3 or 4
- Journeys abroad the last six months to countries high in antibiotic resistance
- Use of food supplements, pre-, -pro, -or symbiotics past one month
- Dysbiosis grade 3 or more by the GA dysbiosis test
Sites / Locations
- University Hospital of North Norway, Harstad
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Preprocessed thawed donor FMT
Preprocessed thawed autologous FMT
The active transplants are processed in a 2-3 weeks period before treatment of the first participant. Fifty to eighty grams of freshly delivered feces from donors is mixed with 100 mL isotonic saline and 25 mL 85% glycerol, homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60 ml luerlock syringes and stored at -40°C. Frozen transplants are slowly thawed 2 hours prior to administration by transferring the FMT-syringes to a waterbath (+30°C). The transplant is then mixed with 125 mL 12°C isotonic saline in an enema bag prior to installation.
The placebo transplant from each participant is prepared during the inclusion process four to six weeks before intervention and stored at -40°C. Fifty to eighty grams of freshly delivered feces from participants is mixed with 100 mL isotonic saline and 25 mL 85% glycerol is homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60ml Luerlock syringes. Frozen transplants are slowly thawed 2 hours prior to administration by transferring the Luerlock syringes to a waterbath (+30°C). The transplant is then mixed with 125 mL 12°C isotonic saline in the enema bag prior to installation.